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EC number: 250-001-7 | CAS number: 30007-47-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- The study was conducted in 1973 prior to establishment of OECD guidelines and GLP- all the significant parameters relating to potential toxicological events have been examined.
- GLP compliance:
- no
- Remarks:
- The study was conducted before the introduction of GLP
- Limit test:
- no
Test material
- Reference substance name:
- 5-bromo-5-nitro-1,3-dioxane
- EC Number:
- 250-001-7
- EC Name:
- 5-bromo-5-nitro-1,3-dioxane
- Cas Number:
- 30007-47-7
- Molecular formula:
- C4H6BrNO4
- IUPAC Name:
- 5-bromo-5-nitro-1,3-dioxane
- Details on test material:
- - Chemical name: 5-Brom-5-nitro- 1,3-dioxan
- Trade name: Bronidox
Constituent 1
- Specific details on test material used for the study:
- The Bronidox is a crystalline substance. The test substance is dissolved in olive oil, under gentle stirring and heating
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mus-Rattus, 8011 Brunntal
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: not given
- Weight at study initiation: Males 145g females 147g
- Fasting period before study: not stated
- Housing: males 2-3 animals /cage females 5 animals /cage
- Diet (e.g. ad libitum): Altromin R-Pressling diât no. 1324 ad libitum
- Water (e.g. ad libitum): municipal drinking water ad libitum
- Acclimation period: 4 weeks after delivery
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24
- Humidity (%): not given
- Air changes (per hr): not given
- Photoperiod (hrs dark / hrs light): natural light conditions
IN-LIFE DATES: From: To: 08-01-1973 to 14-05-1973
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- Test concentrations were prepared fresh 1-2 times a week
1ml preparation/100g bodyweight - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 14 weeks
- Frequency of treatment:
- 5 days per week (not weekends)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- increased to 200 mg/kg bw/day in week 7
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- from week 7 until sacrifice of group
- No. of animals per sex per dose:
- 10 (ten)
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the start and end of the study
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: 10 male/ 10 female
- Parameters below were examined.:
Haemoglobin
Erythrocyte number
Leukocyte number
differential white blood cell count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the start and end of the study
- Animals fasted: Not specified
- How many animals: 10 male/ 10 female
- Parameters below were examined.:
Glutamate-Oxaloacetate Transaminase
Glutamate-Pyruvate Transaminase
Alkaline Phosphatase
Calcium
Glucose
Urea
Additonal parameters measured at sacrifice:
total albumin
Lactate dehydrogenase
URINALYSIS: Yes
- Time schedule for collection of urine: last day of study
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Not specified
- Parameters below were examined:
Urine output
pH
albumin
glucose
Urobilinogen
Ketone bodies
Density
blood
Urinary sediment: epithelia, leukocytes, erythrocytes, bacteria, Urate crystals, calcium oxalate, triphosphate
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No
OTHER: - Sacrifice and pathology:
- At the end of the experiment, all rats were in anethetised in ether, exsanguinated by cardiac puncture and dissected. Internal
Organs were examined macroscopically. The most important
Organs were removed and the absolute wet weights determined.
After weighing the following organs were preserved in 20% Formalin :
Salivary glands
Lungs
Heart
Lymph nodes
spleen
liver
Pancreas
kidney
stomach
Small intestine
large intestine
testicles
Uterus
ovary
adrenals
Thyroid gland
secondary gland
Cerebellum
brain - Statistics:
- The determination of the means, standard deviations, the
upper and the lower confidence limits were determined using statistical software (not specified)
Test for significance:
parametric: t-test
non-parametric: U test
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Animals treated with 200 mg/kg bw/day following week 7 demonstrated apathy, piloerection and haunch squatting
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 2 animals died following the first dosing at 200 mg/kg bw/day and a third following the second dosing. Treatment suspended.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No dose dependent decreases in body weight changes observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- female 10 mg rats:Reduction of hemoglobin and increase in the number of white blood cells.
The male 50 mg animals had a significant increase in hemoglobin content compared to controls
as well as a lowering of the leukocyte number. In Female rats of this group the hemoglobin content was also increased as well as
significant increases in leukocyte count
Despite the valuses being significantly different from controls, they are in the normal range for studies conducted in this species. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 10 mg males- slight reduction in serum protein
50 mg females- increases in Glutamate-Oxaloacetate Transaminase and glucose.
These findings were not dose dependent and are considered incidental findings. - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Reduction in specific gravity of urine in 10 mg/kg/day males and 50 mg/kg/day females.
These findings were not dose dependent and are considered incidental findings. - Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The male animals of the 10 mg group showed decreased absolute organ weights of brain, kidneys,
Gonads and liver; in the female animals of this group slightly lower weights of thyroid. The lowered absolute organ weights of the brain were also observed in
male and female rats of the 50 mg group. The discrepancies in terms of significance between absolute and relative organ weights indicate that the different end-body weights
here were relevant to the differences. Histologically there are no conspicuous, substance-related changes in the above organs. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In the prematurely killed rats of the highest dose, local findings in the stomach were ablation of the mucus
membrane, necrotic changes in the fundus of the stomach as well
slight enlargement of the regional lymph nodes. The enlarged adrenal glands at
the lower dosages were not susbstance related. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- In group I (Bronindox 200 mg / kg / day):
Mucosal necrosis and purulent mucosal inflammation
in the cutaneous stomach, single cell necroses and slightly increased single-cell fatty degeneration in the liver, increased hypoxotic changes in the heart, progressive transformation of the adrenal cortex and easy activation of the lymph nodes.
In group 2 (Bronindox 10 mg / kg / day) found in 2 of 2 animals a leukocyte inflammation in the
Mucous membrane of the cutaneous stomach. The other organs showed no significant differences from the controls. - Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- mortality
Target system / organ toxicity
open allclose all
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw/day (nominal)
- System:
- gastrointestinal tract
- Organ:
- stomach
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw/day (nominal)
- System:
- hepatobiliary
- Organ:
- liver
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw/day (nominal)
- System:
- cardiovascular
- Organ:
- heart
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
Applicant's summary and conclusion
- Conclusions:
- Based upon the folowing effect observed in animals initially dosed with 100 mg/kg bw/day and subsequently increased to 200 mg/kg bw/day in week 7: Mucosal necrosis and purulent mucosal inflammation in the cutaneous stomach, single cell necroses and slightly increased single-cell fatty degeneration in the liver, increased hypoxic changes in the heart, progressive transformation of the adrenal cortex and activation of the lymph nodes, the NOAEL for this substance in Han Wistar rats has be determined to be 50 mg/kg bw/day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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